MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH BSKT SCP UPSWPT 1.3MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	012031
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the device broke during surgery.It is unknown if there was delay in the procedure.A back-up device was available.No patient injury or other complications were reported.
Additional Manufacturer Narrative
One 012031 upswept scoop punch basket instrument reported on.Due to unavailability of the device, definitive conclusions, accurate investigation and evaluation were limited without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Product met specifications upon release to distribution.No further investigation is warranted at this time.Event description updated.
Event or Problem Description
It was reported that the device broke during surgery.No delay reported.A back-up device was available.No patient injury or other complications were reported.
Additional Manufacturer Narrative
One 012031 1.3mm upsewpt scoop punch basket instrument used for treatment, was returned for evaluation.This is a two year old reusable instrument.Functional test was not possible as the product arrived disassembled and not all pieces were returned.The scissor handle section is intact.The front end assembly is in pieces and the articulating jaw component was absent.The actuator has had work done to it and is also damaged in the tip area.The lower basket component cutting edge has dull and wavy edges.The condition is aligned with the distal tip being used for leverage, being twisted or pulled.No root cause related to the manufacturing of this device was confirmed.

• Brand Name: PCH BSKT SCP UPSWPT 1.3MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8542047
• Report Number: 1219602-2019-00458
• Device Sequence Number: 368004
• Product Code: NBH
• UDI-Device Identifier: 03596010023599
• UDI-Public: 03596010023599
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: D164484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 012031
• Device Lot Number: 50638336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 06/10/2019; 08/27/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 06/11/2019; 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1